氨氯地平贴片的体外释药特性

The in vitro release characteristics of amlodipine patch

目的:研究氨氯地平贴片体外释药特性和离体透皮吸收行为。方法:采用HPLC法测定制剂中氨氯地平的含量,按中国药典方法进行体外释放度的测定,利用改良Franz扩散池研究贴片的透皮吸收行为。结果:体外释药特性符合Higuchi方程,释放速率为14.59μg.cm-2.h-1。离体透皮吸收行为符合零级动力学过程,渗透速率为12.73μg.cm-2.h-1。结论:氨氯地平贴片是皮肤控释型透皮给药系统,为临床治疗高血压提供了新的给药途径。

OBJECTIVE To prepare the amlodipine patch and to study its release and percutaneous absorption characteristics in vitro. METHODS The amlodipine patch was prepared with polyisobutylene as pressure sensitive adhesive. The determination method of amlodipine was established using HPLC method. The in vitro release characteristics was studied according to the requirement of Chinese Pharmacopoeia （2000） and the percutaneous absorption characteristics of amlodipine patch was evaluated with the Franz diffusion cell. RESULTS The release mechanisms of amlodipine patch in vitro coincide with Higuchi Equation, the release rate was 14. 59 g.cm^-2, h^-1. Amlodipine patch permeated skin part from body in vitro at the speed of 12. 73 g,cm^-2 ,h^-1 by zero-order kinetics. CONCLUSION The amlodipine patch is a skin controlled transdermal delivery system, its permeation speed is controlled by skin.